HUMAN INSULIN
DESCRIPTION:
*************************************************
* *
* WARNINGS: *
* INFORMATION FOR THE PATIENT *
* THIS LILLY HUMAN INSULIN PRODUCT DIFFERS *
* FROM ANIMAL-SOURCE INSULINS BECAUSE IT IS *
* STRUCTURALLY IDENTICAL TO THE INSULIN *
* PRODUCED BY YOUR BODY'S PANCREAS AND *
* BECAUSE OF ITS UNIQUE MANUFACTURING *
* PROCESS. *
* ANY CHANGE OF INSULIN SHOULD BE MADE *
* CAUTIOUSLY AND ONLY UNDER MEDICAL *
* SUPERVISION. CHANGES IN PURITY, STRENGTH, *
* BRAND (MANUFACTURER), TYPE (REGULAR, NPH, *
* LENTE(R), ETC), SPECIES (BEEF, PORK, BEEF- *
* PORK, HUMAN), AND/OR METHOD OF MANUFACTURE *
* (RECOMBINANT DNA VERSUS ANIMAL-SOURCE *
* INSULIN) MAY RESULT IN THE NEED FOR A *
* CHANGE IN DOSAGE. *
* SOME PATIENTS TAKING HUMINSULIN(R) (HUMAN *
* INSULIN, RECOMBINANT DNA ORIGIN, LILLY) MAY *
* REQUIRE A CHANGE IN DOSAGE FROM THAT USED *
* WITH ANIMAL-SOURCE INSULINS. IF AN *
* ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE *
* FIRST DOSE OR DURING THE FIRST SEVERAL *
* WEEKS OR MONTHS. *
* *
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DIABETES
Insulin is a hormone produced by the pancreas, a large gland that lies near the
stomach. This hormone is necessary for the body's correct use of food,
especially sugar. Diabetes occurs when the pancreas does not make enough insulin
to meet your body's needs.
To control your diabetes, your doctor has prescribed injections of insulin to
keep your blood glucose at a nearly normal level. Proper control of your
diabetes requires close and constant cooperation with your doctor. In spite of
diabetes, you can lead an active, healthy, and useful life if you eat a balanced
diet daily, exercise regularly, and take your insulin injections as prescribed.
You have been instructed to test your blood and/or your urine regularly for
glucose. If your blood tests consistently show above- or below- normal glucose
levels or your urine tests consistently show the presence of glucose, your
diabetes is not properly controlled and you must let your doctor know.
Always keep an extra supply of insulin as well as a spare syringe and needle on
hand. Always wear diabetic identification so that appropriate treatment can be
given if complications occur away from home.
70/30 HUMAN INSULIN
HUMINSULIN is synthesized in a non-disease-producing special laboratory strain of Escherichia Coli bacteria that has been genetically altered by the addition of the gene for human insulin production. HUMINSULIN 70/30 is a mixture of 70% HumanInsulin Isophane Suspension and 30% Human Insulin Injection. It is an
intermediate-acting insulin combined with the more rapid onset of action of
regular insulin. The duration of activity may last up to 24 hours following
injection. The time course of action of any insulin may vary considerably in
different individuals or at different times in the same individual. As with all
insulin preparations, the duration of action of HUMINSULIN 70/30 is dependent on
dose, site of injection, blood supply, temperature, and physical activity.
HUMINSULIN 70/30 is a sterile suspension and is for subcutaneous injection only. It
should not be used intravenously or intramuscularly. The concentration of
HUMINSULIN 70/30 is 100 units/mL (U-100).
IDENTIFICATION
Human insulin manufactured by Eli Lilly and Company has the trademark HUMINSULIN
and is available in 5 formulations--Regular (R), NPH (N), Lente (L),
Ultralente(R) (U), 50% Human Insulin Isophane Suspension (NPH)/50% Human Insulin
Injection (buffered regular) (50/50),. Your doctor has prescribed the type of insulin that he/she believes is best for you. DO NOT USE ANY OTHER INSULIN EXCEPT ON HIS/HER ADVICE AND DIRECTION.
Always check the carton and the bottle label for the name and letter designation
of the insulin you receive from your pharmacy to make sure it is the same as
that your doctor has prescribed. HUMINSULIN 70/30 can be identified as follows:
Always examine the appearance of your bottle of insulin before withdrawing each
dose. A bottle of HUMINSULIN 70/30 must be carefully shaken or rotated before each
injection so that the contents are uniformly mixed. HUMINSULIN 70/30 should look
uniformly cloudy or milky after mixing. Do not use it if the insulin substance
(the white material) remains at the bottom of the bottle after mixing. Do not
use a bottle of HUMINSULIN 70/30 if there are clumps in the insulin after mixing
(Figure 1). Do not use a bottle of HUMINSULIN 70/30 if solid white particles stick
to the bottom or wall of the bottle, giving it a frosted appearance (Figure 2).
Always check the appearance of your bottle of insulin before using, and if you
note anything unusual in the appearance of your insulin or notice your insulin
requirements changing markedly, consult your doctor.
WARNINGS:
*************************************************
* *
* WARNINGS *
* INFORMATION FOR THE PATIENT *
* THIS LILLY HUMAN INSULIN PRODUCT DIFFERS *
* FROM ANIMAL-SOURCE INSULINS BECAUSE IT IS *
* STRUCTURALLY IDENTICAL TO THE INSULIN *
* PRODUCED BY YOUR BODY'S PANCREAS AND *
* BECAUSE OF ITS UNIQUE MANUFACTURING *
* PROCESS. *
* ANY CHANGE OF INSULIN SHOULD BE MADE *
* CAUTIOUSLY AND ONLY UNDER MEDICAL *
* SUPERVISION. CHANGES IN PURITY, STRENGTH, *
* BRAND (MANUFACTURER), TYPE (REGULAR, NPH, *
* LENTE(R), ETC), SPECIES (BEEF, PORK, BEEF- *
* PORK, HUMAN), AND/OR METHOD OF MANUFACTURE *
* (RECOMBINANT DNA VERSUS ANIMAL-SOURCE *
* INSULIN) MAY RESULT IN THE NEED FOR A *
* CHANGE IN DOSAGE. *
* SOME PATIENTS TAKING HUMINSULIN(R) (HUMAN *
* INSULIN, RECOMBINANT DNA ORIGIN, LILLY) MAY *
* REQUIRE A CHANGE IN DOSAGE FROM THAT USED *
* WITH ANIMAL-SOURCE INSULINS. IF AN *
* ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE *
* FIRST DOSE OR DURING THE FIRST SEVERAL *
* WEEKS OR MONTHS. *
* *
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DOSAGE AND ADMINISTRATION:
INJECTION PROCEDURES
CORRECT SYRINGE
Doses of insulin are measured in UNITS. U-100 insulin contains 100 units/mL (1
mL=1 cc). With HUMINSULIN 70/30, it is important to use a syringe that is marked
for U-100 insulin preparations. Failure to use the proper syringe can lead to a
mistake in dosage, causing serious problems for you, such as a blood glucose
level that is too low or too high.
SYRINGE USE
To help avoid contamination and possible infection, follow these instructions
exactly.
Disposable syringes and needles should be used only once and then discarded.
NEEDLES AND SYRINGES MUST NOT BE SHARED.
Reusable syringes and needles must be sterilized before each injection. FOLLOW
THE PACKAGE DIRECTIONS SUPPLIED WITH YOUR SYRINGE. Described below are 2 methods
of sterilizing.
BOILING
1. Put syringe, plunger, and needle in strainer, place in saucepan, and cover
with water. Boil for 5 minutes.
2. Remove articles from water. When they have cooled, insert plunger into
barrel, and fasten needle to syringe with a slight twist.
3. Push plunger in and out several times until water is completely removed.
ISOPROPYL ALCOHOL
If the syringe, plunger, and needle cannot be boiled, as when you are traveling,
they may be sterilized by immersion for at least 5 minutes in Isopropyl Alcohol,
91%. Do not use bathing, rubbing, or medicated alcohol for this sterilization.
If the syringe is sterilized with alcohol, it must be absolutely dry before use.
PREPARING THE DOSE
1. Wash your hands.
2. Carefully shake or rotate the insulin bottle several times to completely mix
the insulin.
3. Inspect the insulin. HUMINSULIN 70/30 should look uniformly cloudy or milky. Do
not use it if you notice anything unusual in the appearance.
4. If using a new bottle, flip off the plastic protective cap, but DO NOT
remove the stopper. When using a new bottle, wipe the top of the bottle with
an alcohol swab.
5. Draw air into the syringe equal to your insulin dose. Put the needle through
rubber top of the insulin bottle and inject the air into the bottle.
6. Turn the bottle and syringe upside down. Hold the bottle and syringe firmly
in 1 hand and shake gently.
7. Making sure the tip of the needle is in the insulin, withdraw the correct
dose of insulin into the syringe.
8. Before removing the needle from the bottle, check your syringe for air
bubbles which reduce the amount of insulin in it. If bubbles are present, hold
the syringe straight up and tap its side until the bubbles float to the top.
Push them out with the plunger and withdraw the correct dose.
9. Remove the needle from the bottle and lay the syringe down so that the
needle does not touch anything.
INJECTION
Cleanse the skin with alcohol where the injection is to be made. Stabilize the
skin by spreading it or pinching up a large area. Insert the needle as
instructed by your doctor. Push the plunger in as far as it will go. Pull the
needle out and apply gentle pressure over the injection site for several
seconds. DO NOT RUB THE AREA. To avoid tissue damage, give the next injection at
a site at least 1/2" from the previous site.
DOSAGE
Your doctor has told you which insulin to use, how much, and when and how often
to inject it. Because each patient's case of diabetes is different, this
schedule has been individualized for you.
Your usual insulin dose may be affected by changes in your food, activity, or
work schedule. Carefully follow your doctor's instructions to allow for these
changes.
PRECAUTIONS:
Other things that may affect your insulin dose are:
ILLNESS
Illness, especially with nausea and vomiting, may cause your insulin
requirements to change. Even if you are not eating, you will still require
insulin. You and your doctor should establish a sick day plan for you to use in
case of illness. When you are sick, test your blood/urine frequently and call
your doctor as instructed.
PREGNANCY
Good control of diabetes is especially important for you and your unborn baby.
Pregnancy may make managing your diabetes more difficult. If you are planning to
have a baby, are pregnant, or are nursing a baby, consult your doctor.
MEDICATION
Insulin requirements may be increased if you are taking other drugs with
hyperglycemic activity, such as oral contraceptives, corticosteroids, or thyroid
replacement therapy. Insulin requirements may be reduced in the presence of
drugs with hypoglycemic activity, such as oral hypoglycemics, salicylates (for
example, aspirin), sulfa antibiotics, and certain antidepressants. Always
discuss any medications you are taking with your doctor.
EXERCISE
Exercise may lower your body's need for insulin during and for some time after
the activity. Exercise may also speed up the effect of an insulin dose,
especially if the exercise involves the area of injection site (for example, the
leg should not be used for injection just prior to running). Discuss with your
doctor how you should adjust your regimen to accommodate exercise.
TRAVEL
Persons traveling across more than 2 time zones should consult their doctor
concerning adjustments in their insulin schedule.
COMMON PROBLEMS OF DIABETES
HYPOGLYCEMIA (INSULIN REACTION)
Hypoglycemia (too little glucose in the blood) is one of the most frequent
adverse events experienced by insulin users. It can be brought about by:
1. Taking too much insulin
2. Missing or delaying meals
3. Exercising or working more than usual
4. An infection or illness (especially with diarrhea or vomiting)
5. A change in the body's need for insulin
6. Diseases of the adrenal, pituitary, or thyroid gland, or progression of
kidney or liver disease
7. Interactions with other drugs that lower blood glucose, such as oral
hypoglycemics, salicylates (for example, aspirin), sulfa antibiotics, and
certain antidepressants
8. Consumption of alcoholic beverages
Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:
-- sweating
-- dizziness
-- palpitation
-- tremor
-- hunger
-- restlessness
-- tingling in the hands, feet, lips, or tongue
-- lightheadedness
-- inability to concentrate
-- headache
-- drowsiness
-- sleep disturbances
-- anxiety
-- blurred vision
-- slurred speech
-- depressive mood
-- irritability
-- abnormal behavior
-- unsteady movement
-- personality changes
Signs of severe hypoglycemia can include:
-- disorientation
-- unconsciousness
-- seizures
-- death
Therefore, it is important that assistance be obtained immediately.
Early warning symptoms of hypoglycemia may be different or less pronounced under
certain conditions, such as long duration of diabetes, diabetic nerve disease,
medications such as beta- blockers, change in insulin preparations, or
intensified control (3 or more insulin injections per day) of diabetes.
A FEW PATIENTS WHO HAVE EXPERIENCED HYPOGLYCEMIC REACTIONS AFTER TRANSFER FROM
ANIMAL-SOURCE INSULIN TO HUMAN INSULIN HAVE REPORTED THAT THE EARLY WARNING
SYMPTOMS OF HYPOGLYCEMIA WERE LESS PRONOUNCED OR DIFFERENT FROM THOSE
EXPERIENCED WITH THEIR PREVIOUS INSULIN.
Without recognition of early warning symptoms, you may not be able to take steps
to avoid more serious hypoglycemia. Be alert for all of the various types of
symptoms that may indicate hypoglycemia. Patients who experience hypoglycemia
without early warning symptoms should monitor their blood glucose frequently,
especially prior to activities such as driving. If the blood glucose is below
your normal fasting glucose, you should consider eating or drinking sugar-
containing foods to treat your hypoglycemia.
Mild to moderate hypoglycemia may be treated by eating foods or drinks that
contain sugar. Patients should always carry a quick source of sugar, such as
candy mints or glucose tablets. More severe hypoglycemia may require the
assistance of another person. Patients who are unable to take sugar orally or
who are unconscious require an injection of glucagon or should be treated with
intravenous administration of glucose at a medical facility.
You should learn to recognize your own symptoms of hypoglycemia. If you are
uncertain about these symptoms, you should monitor your blood glucose frequently
to help you learn to recognize the symptoms that you experience with
hypoglycemia.
If you have frequent episodes of hypoglycemia or experience difficulty in
recognizing the symptoms, you should consult your doctor to discuss possible
changes in therapy, meal plans, and/or exercise programs to help you avoid
hypoglycemia.
HYPERGLYCEMIA AND DIABETIC ACIDOSIS
Hyperglycemia (too much glucose in the blood) may develop if your body has too
little insulin. Hyperglycemia can be brought about by:
1. Omitting your insulin or taking less than the doctor has prescribed
2. Eating significantly more than your meal plan suggests
3. Developing a fever, infection, or other significant stressful situation.
In patients with insulin-dependent diabetes, prolonged hyperglycemia can result
in diabetic acidosis. The first symptoms of diabetic acidosis usually come on
gradually, over a period of hours or days, and include a drowsy feeling, flushed
face, thirst, loss of appetite, and fruity odor on the breath. With acidosis,
urine tests show large amounts of glucose and acetone. Heavy breathing and a
rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or
diabetic acidosis can lead to nausea, vomiting, dehydration, loss of
consciousness or death. Therefore, it is important that you obtain medical
assistance immediately.
LIPODYSTROPHY
Rarely, administration of insulin subcutaneously can result in lipoatrophy
(depression in the skin) or lipohypertrophy (enlargement or thickening of
tissue). If you notice either of these conditions, consult your doctor. A change
in your injection technique may help alleviate the problem.
ALLERGY TO INSULIN
Local Allergy--Patients occasionally experience redness, swelling, and itching
at the site of injection of insulin. This condition, called local allergy,
usually clears up in a few days to a few weeks. In some instances, this
condition may be related to factors other than insulin, such as irritants in the
skin cleansing agent or poor injection technique. If you have local reactions,
contact your doctor.
Systemic Allergy--Less common, but potentially more serious, is generalized
allergy to insulin, which may cause rash over the whole body, shortness of
breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe
cases of generalized allergy may be life threatening. If you think you are
having a generalized allergic reaction to insulin, notify a doctor immediately.
DRUG INTERACTIONS:
MEDICATION
Insulin requirements may be increased if you are taking other drugs with
hyperglycemic activity, such as oral contraceptives, corticosteroids, or thyroid
replacement therapy. Insulin requirements may be reduced in the presence of
drugs with hypoglycemic activity, such as oral hypoglycemics, salicylates (for
example, aspirin), sulfa antibiotics, and certain antidepressants. Always
discuss any medications you are taking with your doctor.
(See Also PRECAUTIONS).
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